Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05887570 |
| Other study ID # |
H11-00779 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 13, 2011 |
| Est. completion date |
July 2, 2024 |
Study information
| Verified date |
November 2023 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Funding for resident training is continually decreasing. The investigators hope to look at
innovative ways to improve resident education. The project will investigate whether skills
acquired in a surgical lab result in improved operating room (OR) surgical skills. This will
be a randomized controlled trial that will split residents up into an intervention group and
a control group. The intervention group will be required to pass training modules for six
essential surgeries before operating in the OR. In the OR, both groups will be graded by the
supervising doctor and be asked to rate themselves using validated questionnaires.
Description:
1. Purpose:
The purpose is to investigate whether procedure-specific skills acquired in a surgical
lab result in improved OR surgical skills; to examine related outcomes of
intra-operative events and resident satisfaction; to examine the feasibility of
implementation of modular training in a gynecology residency program.
2. Hypothesis: That the surgical training modules proposed will improve resident surgical
skills in the operating room.
3. Justification:
Increasing constraints are placed on the educational experience of young surgical
trainees. Specifically in the area of Obstetrics and Gynecology (ObGyn), residents are
expected to become skilled surgeons in addition to acquiring vast knowledge on a myriad
of women's health topics. Operating room (OR) time is scarce. Medicolegal concerns can
be a limitation to resident involvement. Financial incentives to support surgical
mentorship are dwindling. With the rapid acceptance and advancement of minimally
invasive surgical techniques in gynecology, there is a learning curve for the attending
surgeons who must familiarize themselves with the techniques first and thus give fewer
practice opportunities to residents.
Traditionally, acquisition of surgical technical skills happens through repetition in
the OR, under the supervision of an experienced surgeon. Because of the above named
constraints, surgical education of residents has been referred to as "education by
random opportunity". Surgical educators have thus attempted to teach in other settings,
remote from the OR. Options have included the use of suturing stations, animal and
cadaver models, videotapes of procedures and laparoscopic simulators. Although the
efficacy of these options is recognized, few ObGyn programs provide formal surgical
curricula and technical skills are still taught mostly in the OR and through lectures. A
survey of all the 266 ObGyn residency programs in the United States, published more than
10 years ago, showed that surgical teaching curricula were only used by 29% of the
programs. A more recent survey conducted in Canada showed that, 10 years later, only 40%
of Canadian ObGyn programs compared to 76% of other surgical residencies used a
program-specific surgical training curriculum. Most Canadian residency program directors
who did not have access to a standard training curriculum wished to have one
implemented. Results of this survey are consistent with other Canadian studies showing
variability in training and assessment of surgical skill across Canada. Without a formal
curriculum, residents may graduate with widely varying surgical skills, currently not
objectively evaluated as a requirement for graduation.
There are obvious advantages to a surgical training curriculum remote from the OR.
Residents can practice basic and advanced skills as many times as necessary to achieve
competency prior to performing surgeries on real patients. Patient safety is thus not
compromised. Dedicated teaching faculty can provide immediate feedback. If training
objectives are not met, mandatory retraining targeted to specific deficient areas can be
undertaken on the same modules.
Many tools are available for designing an appropriate specialty-specific curriculum. A
review of these tools concluded that based on the available evidence a successful
curriculum would include didactic training and surgical anatomy, the practice of
surgical skills on box trainers and animal models followed by consolidation of skills in
the real OR). A Canadian curriculum with surgical training in various core surgical
skills did not result in improvement in performance of actual surgical procedures on a
cadaver assessment model. On the other hand, a laparoscopic training module in basic
laparoscopic tasks has been shown to impart skills transferable to real OR General
Surgery procedures. In ObGyn, transferability of skills to the OR has been demonstrated
after instruction via procedure-specific modules for laparoscopic tubal ligation and
episiotomy repair.
Our primary aim in the current study is to investigate whether instruction via
procedure-specific surgical modules results in transferability of resident surgical
skill to real OR urogynecologic procedures. Secondary aims include impact of this
instruction on patient outcomes, resident case volume, need for remedial instruction,
cost and feasibility as well as resident satisfaction and self-confidence. Our ultimate
long-term goal is to disseminate our findings across Canada and hopefully encourage all
ObGyn programs to adopt an evidence-based, competency-based, modular, standard training
approach to training gynecologic surgeons.
4. Objectives:
Primary: To investigate whether procedure-specific skills acquired in a surgical lab
result in improved OR surgical skills as tested via a global rating scale on each of
several index procedures.
Secondary:
- To investigate whether procedure-specific skills acquired in a surgical lab result
in improved knowledge of procedural steps on each of several index procedures
- To investigate whether procedure-specific skills acquired in a surgical lab result
in less OR time, fewer intraoperative complications and less blood loss on each of
several index procedures
- To examine how the implementation of modular training affects resident case volume
in the first two months after implementation.
- To determine the proportion of residents needing remedial training after module
completion and examine the feasibility of retraining given constraints of time and
cost
- To examine the cost of implementation of modular training in urogynecology
procedures in a gynecology residency program.
- To examine resident satisfaction and self-confidence with operative skills after
modular training
5. Research Method:
Design This study is a randomized controlled trial of an intervention group, consisting
of surgical training in specific urogynecologic procedures via modules versus a control
group, consisting of usual training. Thirty ObGyn junior residents having performed less
than five of each index procedure independently will be recruited to participate.
Baseline demographics and number of index procedures performed independently prior to
enrollment will be recorded. A baseline knowledge pretest consisting of multiple choice
and short answer questions on technical aspects of the index procedures will be
administered to all residents. The residents in the intervention group will then receive
individual training. Each index procedure will be taught using a module. Each
procedure-specific module consists of a didactic component, practice on suturing, knot
tying and technical aspects of the procedure with individual feedback, and evaluation.
Evaluation consists of a knowledge posttest and a practical examination of acquired
surgical skills on procedure-specif practical models. If the resident fails the written
or practical examinations, he/she will not be allowed to perform surgery in the real OR
but will undergo mandatory retraining using the same modules. When considered competent
by passing the written and practical examinations, the resident will then be allowed to
independently perform corresponding index procedures in the real OR and will be
evaluated via a validated global rating scale of surgical skill. The residents in the
control group will undergo training as usual by individual reading and observation and
practice in the OR. When allowed to independently perform one of the index procedures,
their performance will be evaluated via a validated global rating scale of surgical
skill. After the data collection is complete on the last index procedure, residents in
the control group will be offered the same surgical training given to the residents in
the intervention group. This will be done to ensure equal training opportunities for all
residents.
Sample Size: We used the GRS developed by Reznick et al11 and previously used to compare
gynaecology residents trained on an episiotomy repair module versus controls. Banks et
al established a 21% significant difference in scores for the episiotomy repair module
versus controls.17 As our index procedures are more advanced then episiotomy repair, we
determined that 50 residents (25 per group) were required to find a 20 point overall
difference (out of 100) in mean global rating scale (GRS) score between intervention and
control residents, with a standard deviation of 25 points (to account for the variation
in surgical skill of residents), 80% power and a significance level of 0.05.
6. Statistical Analysis:
Statistical analysis
1. Primary outcome: Student's t-test for Global Rating Scale score average on each index
procedure in the OR - intervention residents versus controls
2. Secondary outcomes: Student's t-test for procedural steps scale score average -
intervention residents versus controls; Mann-Whitney test for average OR time (expressed
in minutes) and estimated blood loss (expressed in milliliters) - intervention residents
versus controls (results likely not normally distributed); descriptive statistics for
intraoperative complications - intervention residents versus controls; student's t-test
for number of cases performed in the OR in the 2 months following intervention -
intervention residents versus controls; proportion of intervention residents requiring
remedial training and cost thereof; cost of implementation of modular training;
student's t-test for Self Confidence Scale score average and satisfaction score average
on each index procedure in the OR - intervention residents versus controls; chi square
test for differences in outcomes based on categorical variables of year of training and
number of previously performed index procedures
